Exact Sciences wins CMS panel vote for Cologuard pricing

Exact Sciences CEO Kevin Conroy

Exact Sciences ($EXAS) has been working hard to expand reimbursement for its stool-based DNA colorectal cancer test since nabbing Medicare coverage last October, signing on two major private insurers earlier this year. Now the company is celebrating a decision from the Centers for Medicare and Medicaid Services (CMS) that could lock in Medicare pricing for its test, delivering another win for the company amid its reimbursement push.

The CMS' advisory panel on Clinical Diagnostic Laboratory Tests voted unanimously 11-0 to maintain Medicare's $429.72 price for Exact's Cologuard test. The panel, which was established under the 2014 Protecting Access to Medicare Act (PAMA), consists of clinical lab experts who examine coverage and payment processes for new lab tests. It was the first time the panel convened, Exact Sciences said in a statement, and the decision follows on the heels of a July meeting which also looked at pricing for the test.

"We're very pleased with the panel's unanimous vote in favor of maintaining the current Medicare reimbursement rate for Cologuard," Exact CEO Kevin Conroy said in a statement. CMS will put out a preliminary determination after considering comments from a July meeting, the recent panel vote and other written comments, delivering a final determination in "the November timeframe" that goes into effect Jan. 1, 2016, he added.

Exact Sciences' Cologuard test--Courtesy of FDA.gov

Last August, Exact won FDA approval for its colorectal cancer screening test and picked up proposed national coverage along the way, benefiting from a joint pilot program from the FDA and the CMS that allows the agencies to simultaneously review medical devices to reduce time between approval and Medicare coverage. Exact's product was the first to take part in the initiative, and the company ended up nailing Medicare coverage for its test a couple months later.

But Exact hit a speed bump in December, when Aetna ($AET) and UnitedHealth ($UNH) decided not to cover Cologuard. Undeterred, Conroy said the company would focus on gaining coverage decisions from large and regional payers. "We would like to see this move along faster and we have a team internally that it focused on it," he said in the company's Q4 earnings statement.

At least so far, things seem to be going well for Exact on the reimbursement front this year. In March, the company nabbed coverage for Cologuard from Aetna and Anthem ($ANTM), making the test available for more than half a million patients.

- read Exact's statement

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